Background information about the job or company:

To ensure regulatory compliance of NARO vaccines and pharmaceuticals product to the national and international standards and regulations.

Responsibilities:

• Ensure that NARO vaccines meet all regulatory requirements
• Oversee the preparation and submission, applications of NARO vaccines and pharmaceutical products to regulatory authorities
• Collaborate with other departments to develop standard operating procedures and ensure compliance with regulations
• Coordinate responses to regulatory agencies regarding product information or issues
• Providing technical and strategic advice regulatory issues on to vaccine management
• Conducting risk assessments of non-compliant situations to determine the best course of action
• Plan regular internal quality self-inspections (audit) program and ensures the necessary budget is allocated to execute internal quality self-inspection
• Prepare corrective and preventive action plans (CAPA) for audit findings with the auditee and follow-up the effective implementation of corrective and preventive action plans (CAPA)
• Continuously collect information about the performance of the work process
• Ensures that the vaccine produced in the production line are manufactured in accordance with Good Manufacturing Practices (GMP)
• Prepare and submit documentation to regulatory agencies
• Review and approve product promotional materials
• Assess the feasibility of new product development
• Collaborate with other departments to ensure appropriate documentations

Qualifications:

• Bachelor of pharmacy degree
• Pharmacy or related field
• 5 years in a in reputable pharmaceutical industry
• Member of pharmaceutical society of Uganda
• Strong understanding of pharmaceutical regulatory environment will be added advantage

Experience needed:

5 years in a in reputable pharmaceutical industry

• Ensure that NARO vaccines meet all regulatory requirements
• Oversee the preparation and submission, applications of NARO vaccines and pharmaceutical products to regulatory authorities
• Collaborate with other departments to develop standard operating procedures and ensure compliance with regulations
• Coordinate responses to regulatory agencies regarding product information or issues
• Providing technical and strategic advice regulatory issues on to vaccine management
• Conducting risk assessments of non-compliant situations to determine the best course of action
• Plan regular internal quality self-inspections (audit) program and ensures the necessary budget is allocated to execute internal quality self-inspection
• Prepare corrective and preventive action plans (CAPA) for audit findings with the auditee and follow-up the effective implementation of corrective and preventive action plans (CAPA)
• Continuously collect information about the performance of the work process
• Ensures that the vaccine produced in the production line are manufactured in accordance with Good Manufacturing Practices (GMP)
• Prepare and submit documentation to regulatory agencies
• Review and approve product promotional materials
• Assess the feasibility of new product development
• Collaborate with other departments to ensure appropriate documentations

• Bachelor of pharmacy degree
• Pharmacy or related field
• 5 years in a in reputable pharmaceutical industry
• Member of pharmaceutical society of Uganda
• Strong understanding of pharmaceutical regulatory environment will be added advantage